As the new year approaches, companies conducting clinical trials in China may want to consider a new regulation that will become effective in March 2024. On November 3, 2023, China’s National Medical Products Administration (“NMPA”) issued a Guideline on Inspection of Drug Clinical Trial Institutions Conducting Studies (Trial Implementation) (“Inspection Guideline” or “Guideline”). The Guideline goes into effect on March 1, 2024.
The Inspection Guideline provides information about procedures for inspections of drug clinical trial institutions (i.e., hospitals and clinics) by national and provincial medical products administrations (“MPAs”) under the authority of the Drug Clinical Trial Institution Regulation, Articles 18-23. A drug clinical trial institution is an institution that has the relevant conditions to support a clinical trial, and complies with Good Clinical Practice for drug clinical trials (“Drug GCP”) and other relevant technical guidelines for conducting drug clinical trials. The Inspection Guideline clarifies the following:
- When are inspections conducted? The Guideline divides inspections into three categories: (1) routine inspections; (2) for-cause inspections; and (3) other inspections, including special inspections. Routine inspections are conducted according to a risk-based annual plan that each provincial MPA establishes. For-cause inspections, by contrast, are triggered when an MPA believes that a drug clinical trial institution may have quality issues, or when an MPA receives complaints about potential violations. MPAs can increase the frequency of inspection of a drug clinical trial institution, if (1) the institution has had serious compliance issues in the past; (2) the clinical investigation team has issues that may affect study quality, including the investigator conducting too many studies at the same time, lack of management skills of the investigator, and insufficient staff on the investigation team; and/or (3) the MPA receives complaints or other indications that the institution has quality problems.
- What happens during a routine inspection? Inspections are primarily on-site, although remote inspections remain an option for MPAs. MPAs should notify the institution five to seven days in advance of a routine inspection. Upon arrival, the MPA inspection team issues a notice of inspection, sets out the scope of the inspection, and explains the rights and responsibilities of the institution. The Drug GCP promulgated in 2020 provides that during inspections, inspectors can access “source data,” “source documents,” and medical records of subjects.
- How is a for-cause inspection conducted differently from a routine inspection? An MPA does not need to notify the institution in advance of a for-cause inspection. Additionally, upon arrival, the inspection team does not need to conduct a meeting with institution staff. By contrast, during a routine inspection, the inspection team would issue the inspection notice, and explain the scope of investigation and the institution’s rights and responsibilities.
- What happens following an inspection? At the end of an inspection, the inspection team should conduct an exit interview, where the inspectors discuss the findings from the inspection. If the institution disagrees with the findings, the institution has an opportunity to respond. The inspection team must then issue a written list of deficiencies. The institution must take corrective actions in response to these deficiencies and submit a corrective action report within 20 business days after the inspection.
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